Condition(s) treated: Obesity

Intervention: Zonisamide (Drug)

Enrollment status: Recruiting. Expecting to enroll 300 people.

Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Principal investigator(s) or official(s):
Kishore M Gadde, MD, Principal Investigator, Affiliation: Duke University

Overall contact:
Gretchen M Yonish, RD, Email: Yonis002@mc.duke.edu

The primary aim of this study is to assess long-term weight loss efficacy of zonisamide relative to placebo in obese patients prescribed a dietary intervention.

Official title: Zonisamide for Weight Reduction in Obese Adults

Study design: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome: Change in body weight

Secondary outcome: Proportions of patients with 5% and 10% weight loss; Waist circumference; Glycaemic indices; Inflammatory markers; Lipids; Quality of life; Psychological measures; Blood pressure

Detailed description: This RCT will compared two doses of zonisamide and placebo for one year. A total of 300 subjects will be enrolled at Duke University Medical Centre. The primary outcome measure is change in body weight in kilograms. Secondary outcomes include changes in waist circumference, glycaemic and inflammatory markers, lipids, food craving, hunger and satiety, quality of life, blood pressure and heart rate.

Minimum eligible age: 18 Years. Maximum eligible age: 65 Years. Eligible gender(s): Both.

Criteria:

Inclusion Criteria: Age 18-65 years; BMI 30-50

Exclusion Criteria:

Secondary obesity; Significant cardiovascular disease; Stroke, seizure disorder or other significant neurological disease; Significant liver or gallbladder disease; Significant renal disease or history of kidney stones; HIV positive status; Diabetes mellitus; Untreated or unstable hypothyroidism Malignancy in the past 5 years; Concomitant medications that cause significant weight gain or weight loss; Concomitant use of prescription or OTC weight loss medications; Had bariatric surgery or planning surgery in the next 1 year; Weight change of more than 4 kg in the past 3 months; Suicidal subjects; Major depression in the past 6 months; History of psychosis, bipolar disorder, or severe personality disorders; Subjects taking antipsychotics or mood stabilisers; Alcohol or substance abuse in the past 6 months; Currently taking zonisamide or other antiepileptic drugs; History of hypersensitivity to zonisamide or sulfonamides; Pregnant or planning pregnancy in the next year, or breastfeeding; Severe physical disability; Current participation in a commercial weight loss program or planning to participate; Currently following low-carbohydrate, high protein, high fat diet; Use of investigational medications or devices (current or past 4 weeks)

-

Gretchen M Yonish, RD, Email: Yonis002@mc.duke.edu

Duke University Medical Centre, Durham, North Carolina 27710, United States; Recruiting

Start date: January 2006
Last updated: September 5, 2006